A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363 or KITE-753, Autologous Anti-CD19/CD20 CAR T-cell Therapies, in Subjects With Relapsed and/or Refractory B-cell Lymphoma
Who is this study for? Patients with relapsed and/or refractory B-cell lymphoma
What treatments are being studied? Cyclophosphamide+Fludarabine+KITE-363
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The goal of this clinical study is to learn more about the safety and effectiveness of the study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory B-cell lymphoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Relapsed and/or refractory B-cell lymphoma (R/R BCL).
• At least 1 measurable lesion.
• Adequate organ and bone marrow (BM) function.
Locations
United States
Arizona
Banner MD Anderson Cancer Center
RECRUITING
Gilbert
California
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
RECRUITING
Duarte
Stanford Cancer Institute
RECRUITING
Stanford
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Georgia
Northside Hospital
RECRUITING
Atlanta
Illinois
Midwestern Regional Medical Center, Inc.City of Hope Chicago
RECRUITING
Park Ridge
Maryland
University of MD, Greenebaum Comprehensive Cancer Center
RECRUITING
Baltimore
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
New York
Columbia University Irving Medical Center
RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
Ohio
The Ohio State University Wexner Medical Center - James Cancer Hospital
RECRUITING
Columbus
Texas
The University of Texas, MD Anderson Cancer Center
RECRUITING
Houston
Virginia
Virginia Oncology Associates
RECRUITING
Norfolk
Other Locations
Australia
Epworth Healthcare
RECRUITING
East Melbourne
Royal North Shore Hospital
RECRUITING
St Leonards
Concord Repatriation General Hospital
RECRUITING
Sydney
Canada
Jewish General Hospital
RECRUITING
Montreal
McGill University Health Center
RECRUITING
Montreal
Germany
Universitatsklinikum Wurzburg
RECRUITING
Würzburg
Netherlands
Academisch Medisch Centrum
RECRUITING
Amsterdam
United Kingdom
King's College Hospital
COMPLETED
London
Contact Information
Primary
Medical Information
medinfo@kitepharma.com
844-454-5483(1-844-454-KITE)
Time Frame
Start Date: 2021-10-27
Estimated Completion Date: 2030-02
Participants
Target number of participants: 247
Treatments
Experimental: Phase 1 a/b: KITE-363
Phase 1a (Dose escalation): Participants with r/r large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-363 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-363.~Phase 1b (Dose expansion): After completion of dose escalation, additional participants with r/r B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-363 at 1 or more dose-level deemed to be tolerable.~\[Recruitment completed for this arm\]
Experimental: Phase 1 a/b: KITE-753
Phase 1a (Dose escalation): Participants with r/r large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-753 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-753.~Phase 1b (Dose expansion): After completion of dose escalation, additional participants with r/r B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-753 at 1 or more dose-level deemed to be tolerable.~\[Recruitment open for frontline LBCL and r/r MCL for this arm\]
Experimental: Phase 2: KITE-753
Participants with r/r large B-cell lymphoma who have received at least 2 prior lines of systemic therapy will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-753 chimeric antigen receptor (CAR) transduced autologous T cells /kg intravenously (IV).
Related Therapeutic Areas
Sponsors
Leads: Kite, A Gilead Company